Earnings Call Transcript - SCYX Q1 2022

Operator, Operator

Greetings and welcome to SCYNEXIS, Inc. First Quarter 2022 Earnings Conference Call. At this time, all participants are in listen-only mode. As a reminder, this conference is being recorded. Now, I'd like to turn the conference over to your host, Debbie Etchison from Investor Relations. Please go ahead, ma'am.

Debbie Etchison, Investor Relations

Thank you. Hello, everyone, and welcome to today's conference call to discuss our First Quarter 2022 Financial Results and Corporate Update. Before we start, let me remind you that today's call will include forward-looking statements based on current expectations, including statements concerning our financial outlook for the future, leadership's expectations for our future financial and operational performance, as well as our business strategy. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Please refer to our filings with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and quarterly report on Form 10-Q, including in each case under the caption Risk Factors, in another document subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements speak only as of today, May 12th, 2022. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. The information on today's call is not intended for promotional purposes and is not sufficient for prescribing decisions. Joining us today on our call is SCYNEXIS President and CEO, Dr. Marco Taglietti, Chief Commercial Officer, Christine Coyne, Chief Medical Officer, Dr. David Angulo, and Interim Chief Financial Officer, Lawrence Hoffman. Following our prepared remarks, we'll open the call to your questions. Now, I will turn the call over to Dr. Marco Taglietti, President and CEO.

Marco Taglietti, CEO

Thank you, Debbie. Good morning, everyone. Thank you for joining us today for our First Quarter of 2022 earnings investor call. We are excited to share with you updates on the progress of the launch of BREXAFEMME and to outline our vision for the future of the ibrexafungerp franchise. 2022 is a pivotal year for SCYNEXIS and we are making great strides. Let me briefly summarize a few key recent accomplishments and near-term goals. On the R&D side, we continue our successful efforts to expand relabeling of ibrexafungerp. We expect to file the supplemental NDA for the recurrent VVC indication this quarter, with an approval by the end of this year. We reported positive results from the new interim analysis of the FURI and CARES trials, highlighting all our ibrexafungerp's potency against severe fungal infections with more than 83% of combined patients demonstrating a clinical response to oral ibrexafungerp. Finally, the MARIO study is being initiated and we expect the first patient to be enrolled soon. The MARIO study is expected to report the results in 2024 with the potential approval for hospital indications by the end of 2024. Dr. David Angulo, our Chief Medical Officer, will provide you with more details on this program and the positive results to date. Our first commercial product, BREXAFEMME, ibrexafungerp tablets, launched in September 2021, achieved nearly 4,000 prescriptions and reached net revenues of $700,000 in the first quarter of 2022. We saw a promising growth trend in the first quarter of 2022, as we continue to boost our efforts to accelerate sales this year and beyond to reach our goals. Our Chief Commercial Officer, Christine Coyne, will discuss the coordinated and integrated actions we are taking to grow prescriptions from our field sales force to launching a direct-to-patient campaign. On the corporate side, we closed the first quarter 2022 with more than $95 million in cash. We feel fortunate and are very thankful to our investors for being able recently to strengthen our available cash with a $45 million public offering, which will enable us to advance our goal of building a broad antifungal franchise for ibrexafungerp across multiple indications. I say fortunate because strengthening our cash situation will allow us to successfully navigate the current environmental challenges of today's world, including the war in Ukraine and the pandemic. Having secured the cash to fund our corporate activities into the first quarter of 2024 puts us in a strong position. Based on our cash, we currently have better resources to support our commercial efforts in VVC, including preparing for the launch in 2023 of recurrent VVC, and we have the resources to complete our hospital programs to enable additional regulatory filings in 2024. By the way, we also continue to look for business development deals like the one we did with Hansoh for Greater China, and for other non-dilutive ways to strengthen our cash balance. I would like to underscore that our vision to make ibrexafungerp a successful, sustainable, and profitable antifungal franchise is becoming a reality. With BREXAFEMME now approved and launched for the treatment of VVC, we plan to expand its labeling by the end of this year to include the prevention of recurrent VVC. We are diligently and successfully following our plan to obtain each key milestone along our path to build a broad, long-lasting antifungal franchise. All these indications, when taken together, will create a franchise with the potential to generate $700 million to $800 million a year in net sales in the U.S. alone. Larry, our Interim CFO, will provide more details on our expenses and cash balance. And then we will open the floor for the Q&A session. Now, I would like to turn the call over to our Chief Commercial Officer, Christine Coyne.

Christine Coyne, Chief Commercial Officer

Thank you, Marco, and good morning. In August 2021, our field reps began calling on their physician targets. Physician interest in learning more about BREXAFEMME was encouraging. We stocked the pharmacy shelves and we began to see doctors prescribing BREXAFEMME. We are off to a strong start while our insurance coverage of commercial lives continued growing and tracked ahead of schedule. However, over the winter, we saw growth trends slowing, mostly because of environmental factors like the Omicron wave that affected the commercial sales force of many other companies as well. Therefore, we have been putting even more efforts into critical success factors, such as reach and frequency of visits to high prescribing healthcare professionals. The good news is, we are now seeing a positive growth trend picking up at a good pace. Our messaging about the benefits of BREXAFEMME is resonating with prescribers, which is great news. We will continue to refine our messaging as we work to broaden our prescriber base. At the same time, we are increasing our patient outreach efforts. Based on the field response to these initiatives, we are seeing these efforts having a positive impact that will help us achieve our target sales. Now let's look at some numbers. Over the last few quarters, we built a base of BREXAFEMME prescribers. Our focus is to continue broadening our prescriber base and helping those doctors to expand their use with more patients. We grew our prescriber base about 10% in the first quarter of 2022, especially with the number of repeat writers growing to almost three times the level as of the fourth quarter of 2021. Repeat prescribers contributed the majority, 56%, of BREXAFEMME volumes in the first quarter of 2022, versus 20% in the fourth quarter of 2021. Over the last few weeks, we have generated learnings from these repeat writers, and we are applying these learnings to all prescribers. BREXAFEMME prescriptions continued to grow over the last quarter. We generated almost 4,000 prescriptions in the first quarter of 2022, representing growth over the last quarter of 2021. The first quarter prescription growth came from adding new prescribers and broader adoption among fourth quarter 2021 prescribers. We continue to see steady progress each month and are encouraged by the most recent growth trends. Our commercial coverage continues to steadily tick higher as payers recognize the benefits and value associated with BREXAFEMME. By the end of the first quarter of 2022, we successfully garnered coverage of more than 93 million commercially insured lives, representing 55% of the commercial universe, up from the 48% of commercially insured lives reported last quarter. We expect continued momentum on this front, as discussions with our payer customers are signaling just this. Our national account directors are very experienced with extensive payer relationships, and the strong coverage numbers demonstrate how important the option of BREXAFEMME is to payers and their patient members. Now that we have built payer coverage, we're coupling it with a new campaign called Say No More. This campaign was launched with healthcare professionals in April and prominently features relatable and iconic imagery paired with new data and messaging. Our next step is to amplify our collective outreach to patients and consumers starting this month. We will reach out to patients with the Say No More campaign. We have been talking to patients, deepening our understanding of what motivates them. Based on these findings, we have changed the language used to describe the key attributes of BREXAFEMME to be more powerful and more robust. Our new marketing materials focus on empowerment, which resonates with our target audiences. Rolling out later this month will be digital advertising, social media advertising, and much more. Say No More is becoming a rallying cry for patients who have been suffering with yeast infections and trying the same solutions to help alleviate their symptoms. Say No More, BREXAFEMME. It's time patients had a new option. The Say No More patient advertising will activate patients and consumers seeking health to learn about BREXAFEMME symptom relief and to ask their doctor for BREXAFEMME. As our field teams solidify our efforts with our key prescribers, we will monitor our augmented patient efforts and amplify those with the greatest impact. We know physicians are pleased with their experience with BREXAFEMME, and we look forward to reporting back on our patient efforts. While our field teams do their work and we launch the patient awareness programs, we have also taken this opportunity to launch additional communication vehicles to create a surround sound of communication. For example, last week we implemented a satellite media tour with two of our spokespeople, Dr. Nkechi Azie, Vice President of Medical Affairs at SCYNEXIS, and Nurse Barb, an expert nurse practitioner. These spokespeople talked to 26 TV and radio stations, highlighting the importance of natural health and the advancements made by SCYNEXIS in the field. The call to action for this successful effort was twofold. We asked viewers to go to our website for more information and the latest advancements to fight yeast infections. The URL redirects to BREXAFEMME.com to drive traffic to the site, and we encouraged them to learn about the new product that kills yeast. These are just a few of the TV stations in key markets across the country where the segments aired and we'll continue to air during the month of May. As you can see, we have efforts across multiple channels that will continue to expand over the next few quarters, and these times are exciting indeed. However, we are pleased but we're not satisfied. It is clear that we have brought a long-needed non-azole option to yeast infection treatments. But that's not enough. We must continue to consistently remind our BREXAFEMME prescribers not to fall into old habits, and we must continue adding new prescribers to our base. We know when we do this, we see a positive impact. While our field teams focus there, we will get these patient outreach efforts out, harmonizing all these promotional levers to help us continue to drive growth. We look forward to reporting back to you on all these efforts. Thank you, and I will now turn the call over to Dr. David Angulo, our Chief Medical Officer.

Dr. David Angulo, Chief Medical Officer

Thank you, Christine. As previously announced, we completed our Phase 3 study CANDLE, evaluating ibrexafungerp for the prevention of recurrent vulvovaginal candidiasis or rVVC. The results were positive, showing significant and sustained response with ibrexafungerp treatment. With these results, we are now on track for submission of a supplemental NDA by the end of this quarter, with an anticipated approval by the end of this year. In the study, ibrexafungerp was well tolerated; there were no serious drug-related adverse events and no patient treated with ibrexafungerp discontinued therapy due to adverse events. The most commonly reported adverse events were headaches and gastrointestinal events, which were mostly mild and generally consistent with the current BREXAFEMME label. In addition, we recently reported positive outcomes in patients with refractory VVC treated with ibrexafungerp from the ongoing Phase 3 study FURI. These results were presented during the annual meeting at the American College of Obstetricians and Gynecologists, ACOG. Ibrexafungerp showed efficacy in difficult-to-treat patients that have VVC refractory to standard antifungal therapies. Fourteen patients with refractory VVC were treated with ibrexafungerp, 750 milligrams every three days for three doses, and 71% of them had successful clinical outcomes as judged by the independent data review committee. In the hospital setting, as you know, we are developing ibrexafungerp to address critical unmet needs, including invasive candidiasis, refractory fungal infections, and invasive aspergillosis. We have initiated the MARIO study evaluating ibrexafungerp as a step-down therapy in patients with invasive candidiasis. We anticipate the first subject to enroll this quarter. The CARES and FURI studies evaluating ibrexafungerp in patients with candidiasis infections and refractory fungal diseases continue progressing well. We estimate having data available from these three studies by early 2024, supporting an NDA submission and an anticipated approval later that year. The Phase 2 study in invasive aspergillosis synergia will continue until the end of this year, and the next steps of development will be guided by data from these studies. As you know, the FURI and CARES studies are open-label and allow the opportunity to do a preliminary evaluation of the outcomes of the patients enrolled with these very difficult-to-treat infections. We recently reported the results from the last interim look at data from these studies, with now more than 130 patients reviewed. We are very pleased to see that the response rate, as evaluated by the external group of experts, continues to be positive. More than 60% of the patients achieved complete or partial response, and 22% achieved stable disease, which is a favorable outcome in cases of progressive fungal infection, resulting in more than 80% of patients experiencing a clinical benefit. The results were positive in both the FURI study, which includes patients with different fungal infections, and in the CARES study, focused on patients with multi-drug-resistant Candida auris. The most common pathogens reported in these groups of patients include fungal strains commonly associated with antifungal resistance, such as Candida glabrata, Candida krusei, and Candida auris. The consistency of this data with previous analyses gives us continued confidence in the potential utility of ibrexafungerp in this space. Finally, our key milestones associated with our development pipeline remain on track, and we continue developing ibrexafungerp for multiple indications, as discussed previously. And now, let me turn the call over to Lawrence Hoffman, our Interim Chief Financial Officer.

Lawrence Hoffman, Interim Chief Financial Officer

Thank you, David. For the first quarter of 2022, BREXAFEMME generated $700,000 in net revenues. As a reminder, we are recording revenue upon the sale of inventory to the wholesaler. The net revenue amount represents sales, excluding discounts to insurers, and also includes any discounts from patient assistance programs like our co-pay card. We expect our net selling price to improve over the course of the year. The cost of product revenue was $100,000 for the first quarter of 2022. R&D expenses for the first quarter of 2022 decreased to $5.7 million from $6.9 million versus the comparable prior year quarter. SG&A expenses for the first quarter of 2022 increased to $14.6 million from $6.7 million versus the first quarter of 2021. The increase of $7.9 million was driven by an increase in commercial expenses related to the ongoing commercialization of BREXAFEMME. Total other income was $9.6 million for the first quarter of 2022 versus total other expenses of $2 million for the first quarter of 2021. During the first quarters of 2022 and 2021, SCYNEXIS recognized non-cash gains of $10 million and $1.3 million respectively from fair value adjustments of warrant liabilities and non-cash gains of $1 million on the fair value adjustments of derivative liabilities. The net loss for the first quarter of 2022 was $5.5 million or $0.17 basic loss per share compared to a net loss of $4.7 million or $0.18 basic loss per share for the comparable prior-year quarter. As Marco mentioned at the start of the call, we have a strong cash runway into the first quarter of 2024. We have cash and cash equivalents of $95.2 million as of March 31, 2022, with an additional $45 million received in gross proceeds, approximately $42 million net after certain costs and expenses, which we received from our common stock offering in April 2022. Our partnership with Hansoh provides us with an additional potential of $112 million in future long-term development and commercial milestones, and the strength of our patent protection and ongoing business development efforts provide us with additional opportunities internationally. Thank you. And before we begin the Q&A, I will turn the call back over to Marco.

Marco Taglietti, CEO

Thank you, Larry. And before we open the floor for a Q&A session, I want to reiterate a few key points. First, I cannot stress enough that we believe the BREXAFEMME therapy is a unique first-in-class systematic antifungal with the right potential. A product around which we can build—and we are building—a long-lasting franchise, helping patients in both the community and hospital settings. Second, we have started to build the franchise by launching BREXAFEMME in VVC in September. BREXAFEMME is making great strides with healthcare professionals and patients. This is only the first of multiple potential indications for ibrexafungerp, as we anticipate expanding the labeling to include recurrent yeast infections by the end of this year. Third, our R&D pipeline is extremely robust, and we expect to enroll the first patient in our MARIO trial this quarter. We anticipate the regulatory approval of our first hospital indication for ibrexafungerp by the end of 2024, as an oral step-down therapy for invasive candidiasis and for interventions in refractory invasive fungal infections. Fourth, not only can we build a broad antifungal franchise, but a franchise that will last for a long time, since we have exclusivity protection until 2035. Finally, we are in a strong financial position with a cash runway into the first quarter of 2024. Now let me finish with our rallying cry: yeast infection, Say No More! I hope you love our new rallying cry. And now, Operator, please open the floor for questions.

Operator, Operator

Thank you, sir. We will now begin the question-and-answer session. The confirmation tone will indicate that your line is in the question queue. Please hold while we take questions. Our first question is from Michael Higgins with Ladenburg Thalmann. Please go ahead.

Michael Higgins, Analyst

Thanks, Operator. Congrats guys on the continued progress. Thanks for taking some questions. With all the activity lately, I want to start with the FURI data if I could. What are your thoughts on the response rates when you compare them to other novel antifungals? How many patients do you at this point project for an NDA filing? Thanks.

Dr. David Angulo, Chief Medical Officer

Thank you, Michael, this is David. Yes, the response rates that we're seeing right now are in a salvage therapy setting, so we are very, very pleased with the response rates. We have been disclosing that for the past years and we're seeing that more than 60% of patients are having complete or partial responses, which is very positive for people who have been already failing other therapies or where other therapies are not available to them. In comparison to what has been reported in the salvage therapy setting, we are very much on target. We expect that the response rate for these particular populations is very good. Regarding the enrollment for these studies, we estimate around 200 subjects for and about 30 subjects for CARES, and we believe we are on target for completion of that enrollment within the timeframe we are disclosing right now.

Michael Higgins, Analyst

That's great. I will double-check my notes. We were looking earlier, and it seemed like we were seeing favorable responses, how it's described in the label of 30% and 40% for the other antifungals when they come out. So really impressive, but thanks for your feedback on that. If I can switch to Christine, a question for you on the BREXAFEMME prescriptions. Do you have for us an update on the percent of prescriptions going to women with rVVC? And has that changed since the last quarter? Thanks.

Christine Coyne, Chief Commercial Officer

Good morning, Michael. Thanks for the question. Are you talking about the market or are you talking about BREXAFEMME prescriptions?

Michael Higgins, Analyst

Yes, BREXAFEMME scripts. How many are going to refractory patients versus on-label?

Christine Coyne, Chief Commercial Officer

Yes, from a commercial standpoint, Michael, we stay on-label. That's all we can do. So the reps are talking to doctors about VVC, not rVVC. That's really what we track are the scripts of VVC.

Marco Taglietti, CEO

But I think Michael; this is Marco; I think you're raising a very good point. Some of the patients classified as recurrent VVC may simply be patients where the fungistatic effect of fluconazole doesn't clear the infection. Therefore, we believe that one of the big advantages of our product is the fungicidal effect that kills the Candida, clears the infection, and provides a cure. This could mean that patients afflicted by these recurrent infections may have not treated and cured their infection effectively. So that is one of the aspects we expect from our product.

Michael Higgins, Analyst

Thanks. And one last question if I could, any update for us on Synergia on how that's enrolling? Thanks.

Dr. David Angulo, Chief Medical Officer

Yes. Thank you, Michael, this is David again. Yes, the Synergia trial, as previously disclosed, has seen enrollment lower than initially projected. However, during this year we have seen much more activity compared to the past couple of years. We are continuing discussions with investigators and will continue enrollment during this year, wrapping up the old information we had by the end of the year, and making a decision regarding subsequent development for invasive pulmonary aspergillosis specifically based on that data. We are looking forward to reporting those results later on.

Marco Taglietti, CEO

Thank you, Michael.

Operator, Operator

Thank you. Please gentlemen, we have next question from the line of Louise Chen with Cantor Fitzgerald. Please go ahead.

Wayne Buchan, Analyst

Hi, this is Wayne Ho for Louise. Congrats on the progress this quarter and thank you for taking our questions here. So my first question is on the competitive landscape. How will the recent approval of Mycovia impact the uptake of BREXAFEMME? And then how is the relationship with Amplity; are they planning to expand a sales force? My last question is, are there any bottlenecks regarding market access challenges that are hindering the uptake of BREXAFEMME? Thank you.

Marco Taglietti, CEO

These are very good questions, Wayne. Let me start with the first one about the competition and Mycovia. We are happy to see that there is finally innovation in the field of VVC. If you think about the last three decades, there has been nothing new for patients with VVC, despite the well-known limitations of azoles. So two approvals in this field in the last 12 months is great news for all women suffering with this condition. We wish well to our colleagues at Mycovia. The two companies have taken different paths. We've decided to develop a unique product in a new class beyond azoles, with a very favorable safety profile, without major restrictions or limitations. Moreover, we expect that when BREXAFEMME is approved for recurrent VVC at the end of this year, it will be the only product approved for both the treatment of VVC and the prevention of recurrent VVC. With easy dosing and indications for a broad range of patients, both in terms of age from 12 years and older, and in terms of women of childbearing potential. In regards to your second question about Amplity, our relationship with Amplity is very clear; they are a contract commercial organization. We are hiring a sales force fully dedicated to SCYNEXIS. One of the reasons we decided to have this type of approach instead of creating our own sales force is because having an organization like Amplity gives us the flexibility to expand when needed without building a large internal structure. Amplity is there to help us be successful, and as you know, this is a partnership that allows us to defer some of the near-term costs. Finally, regarding the distribution, our supply chain has been working extremely well. We were able to get the product into pharmacies at the end of August or beginning of September. I would like to remind you that SCYNEXIS has been a manufacturing company for nearly two decades. We know how to develop, produce, and manufacture a product, and the supply chain has been remarkably successful. We do not see any issues with pharmacy access. But let me have Christine confirm that aspect to ensure I haven’t missed anything.

Christine Coyne, Chief Commercial Officer

You did not. Thanks, Marco. Hi, Wayne, thanks for the question. You're absolutely right, Marco. We did not have any trouble getting the product into the retail pharmacies or into the market. Regarding your second question about potential obstructions related to how the prescriptions are adjudicated for the patient, we have not seen any challenges. We've enjoyed a good access, with the 93 million commercial lives we opened up from last year into this quarter being really helpful. Our copay support program is benefiting patients, and expectations are positive as more commercial lives get covered. We are closely monitoring this aspect and are focused on ensuring our reps are in front of their high-prescribing targets. We see great results when that happens.

Wayne Buchan, Analyst

Thank you, Christine. Congrats again.

Christine Coyne, Chief Commercial Officer

Thanks.

Marco Taglietti, CEO

Thank you, Wayne.

Operator, Operator

Thank you. We have the next question from the line of Kumar Raja with Brookline Capital, please go ahead.

Unidentified Analyst, Analyst

Hi, I'm Tremendo for Kumar. Thank you for the update. I was just wondering if you could provide some color on the ongoing Phase 3 MARIO studies. How many sites are you planning to activate? Do you expect all the sites to come on board at the same time? Thank you.

Dr. David Angulo, Chief Medical Officer

Sure, this is David. Thank you for the question. As for your second part about the timing of site activation, no, not all sites will come on board at the same time. Typically in these large global Phase 3 studies, different regions come online at different times due to varying regulatory timelines for approval. We are conducting a feasibility assessment of all geographic regions; this study will involve centers in Europe, Asia, and the United States. The initial centers have already opened for enrollment, and we are confident in our ability to enroll our first patient within this quarter. The total number of sites we are estimating is between 70 to 80 sites globally.

Unidentified Analyst, Analyst

That was helpful. Thank you. So you had some preclinical data with mucormycosis. How are you planning to take it to the clinics? Do you have any patients enrolling for a combination therapy in the ongoing studies? Thank you.

Marco Taglietti, CEO

Yes, we do have patients enrolling with combination therapy for other fungal diseases, rare pathogens, but not specifically for mucormycosis. The preclinical investigations indicated that we observed that the combination therapy of amphotericin B with ibrexafungerp had surprisingly good results in mucormycosis. We presented these findings to the scientific community and are now notifying the investigators of the FURI study that they have the opportunity to enroll patients with mucor infections in the study. In the past, we were not enrolling patients with mucor due to limited information regarding the clinical utility of ibrexafungerp, but now we are opening this study for them, and we are looking forward to observing the clinical activity for this indication.

Unidentified Analyst, Analyst

Okay, great. Thank you so much for taking my questions.

Marco Taglietti, CEO

Thank you.

Operator, Operator

Thank you. We have the next question from the line of Oren Livnat with H.C. Wainwright. Please go ahead.

Oren Livnat, Analyst

Thanks for taking the questions. I have a couple. The first on ibrexafungerp—there seems to be a change in messaging focusing on empowerment, and I'm detecting a focus on high prescribers. Can you clarify if there has been a change in strategy with regards to resource allocation and targeting? Are you backing off efforts to broaden the prescriber base and focusing more on deepening, increasing the frequency of writing among high prescribers? Then I'll ask a follow-up.

Christine Coyne, Chief Commercial Officer

Hi Oren, good morning. It's Christine, thank you for the question. You have understood the situation accurately; we target high prescribers, mainly OB-GYNs. They are vital to our base. Some offices experienced COVID-related closures, and when our reps could not go in frequently, it affected prescriptions. As offices reopened, our reps returned and saw an improvement in prescribing rates. So there has been no change in strategy; we are continuing to execute our plan and ensure we are getting into the high prescribers' offices as often as possible.

Oren Livnat, Analyst

And as far as the messaging, is the new messaging for patients primarily, or is the pitch to doctors changing as well?

Christine Coyne, Chief Commercial Officer

Yes, we have been adding learned insights based on our experiences over the nine months since launch. We listen to customers and refine our messaging, including the language and imagery, to ensure higher memorability. This includes making our messaging more evocative to resonate with our target audiences, but it doesn't represent a strategy shift.

Oren Livnat, Analyst

Thank you very much. Appreciate it. Good luck!

Marco Taglietti, CEO

Thank you all. Thank you, Oren.

Operator, Operator

Thank you. Ladies and gentlemen, we have reached the end of the question-and-answer session. I would like to turn the call back to Marco Taglietti, CEO, for closing remarks. Over to you, sir.

Marco Taglietti, CEO

Thank you very much, Operator. I would like to briefly emphasize some key points: 2022 is a critical year. We started very well in all three major areas. We are launching BREXAFEMME with a positive trend, generating impressive data in the hospital setting, and we have a solid financial foundation that ensures we have the resources to support all our efforts with a cash runway into 2024. We couldn't have started 2022 any better. Thank you for your attention and support. Operator, you can close the call.

Operator, Operator

Thank you, sir. Ladies and gentlemen, this concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.